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A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416987
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date August 12, 2011
First Posted Date August 15, 2011
Results First Submitted Date May 9, 2019
Results First Posted Date July 19, 2019
Last Update Posted Date July 19, 2019
Actual Study Start Date August 14, 2011
Actual Primary Completion Date May 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019)
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) [ Time Frame: 2463 days ]
Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
Original Primary Outcome Measures
 (submitted: August 12, 2011)
Frequency and severity of all adverse events regardless of the causal relationship to Pergoveris® [ Time Frame: 30 month ]
Change History
Current Secondary Outcome Measures
 (submitted: May 9, 2019)
  • Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography [ Time Frame: 2463 days ]
    Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
  • Number of Participants With Clinical Pregnancy as Per Safety Analysis Set [ Time Frame: 2463 days ]
    The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
  • Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set [ Time Frame: 2463 days ]
    The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Original Secondary Outcome Measures
 (submitted: August 12, 2011)
  • Clinical pregnancy [ Time Frame: 30 month ]
  • Percentage of patients with more than one follicle greater than 17mm on day of human chorionic gonadotrophin (HCG) administration [ Time Frame: 30 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Official Title A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Brief Summary

This prospective study collected safety information from more than 600 participants treated with Pergoveris®.

During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infertile participants
Condition Infertility
Intervention Drug: Pergoveris®
Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2011)
600
Original Estimated Enrollment Same as current
Actual Study Completion Date May 10, 2018
Actual Primary Completion Date May 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food & Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"

Exclusion Criteria:

  • According to national label
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01416987
Other Study ID Numbers EMR200061-507
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor Merck KGaA, Darmstadt, Germany
Collaborators Merck Ltd.
Investigators
Study Director: Medical Responsible Merck Ltd.
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date May 2019